Acor­da gets a bad­ly need­ed PDU­FA date with the FDA on Parkin­son's drug; Take­da signs neu­ro­log­i­cal col­lab­o­ra­tion with an­ti­sense play­er Wave Life Sci­ences

Acor­da $ACOR says that the FDA has fi­nal­ly ac­cept­ed their ap­pli­ca­tion for In­bri­ja (CVT-301), putting their in­haled form of lev­odopa for Parkin­son’s on track for a mar­ket­ing de­ci­sion by Oc­to­ber 5. The reg­u­la­to­ry ad­vance comes 6 months af­ter the agency ini­tial­ly re­fused to file their ap­pli­ca­tion, which now leaves the FDA due to make a de­ci­sion by Oc­to­ber. That’s a big deal at Acor­da, as its last re­main­ing patent pro­tect­ing its big drug Ampyra is set to ex­pire this sum­mer, leav­ing them stripped of any le­gal ar­mor against the gener­ics that will shred that mar­ket. Acor­da re­lies on Ampyra for al­most all of its rev­enue.

Take­da has beefed up its neu­ro­science di­vi­sion with a four-year, mul­ti-pro­gram op­tion col­lab­o­ra­tion with Wave Life Sci­ences that cov­ers re­search, de­vel­op­ment and com­mer­cial­iza­tion. An­ti­sense oligonu­cleotides for ge­net­i­cal­ly de­fined neu­ro­log­i­cal dis­eases is the over­ar­ch­ing theme of the pact, which is bro­ken down in­to two parts: the first in­volves the op­tion to co-de­vel­op and co-com­mer­cial­ize cer­tain pro­grams cur­rent­ly un­der­go­ing clin­i­cal proof of mech­a­nism, while the sec­ond gives Take­da the rights to ex­clu­sive­ly li­cense pre­clin­i­cal pro­grams. Part 1 in­ves­ti­gates ther­a­pies tar­get­ing Hunt­ing­ton’s dis­ease, Lou Gehrih’s dis­ease, fron­totem­po­ral de­men­tia and spin­ocere­bel­lar atax­ia type 3; part 2 deals with oth­er neu­ro­log­i­cal dis­or­ders in­clud­ing Alzheimer’s and Parkin­son’s.

→ Hav­ing formed strate­gic part­ner­ships with Take­da Ven­tures in Japan and UCB Phar­ma in Bel­gium, Ar­ix Bio­science has turned to Chi­na for its lat­est col­lab­o­ra­tion — with Hong Kong-list­ed Fo­s­un In­ter­na­tion­al as its part­ner. The plan is to in­vest in and cre­ate new com­pa­nies to­geth­er on a broad range of new clin­i­cal ther­a­pies, with an em­pha­sis on the grow­ing Chi­nese mar­ket. Ar­ix will pro­vide ac­cess to its group busi­ness­es, pipeline and peo­ple net­work in ex­change for Fo­s­un’s knowl­edge of po­ten­tial in­vest­ment op­por­tu­ni­ties. Al­ready teamed up with Kite in a joint ven­ture, “Fo­s­un’s ex­ten­sive foot­print and net­work in Chi­na will en­hance Ar­ix’s al­ready strong sourc­ing pow­er and pro­vide our Group Busi­ness­es the op­por­tu­ni­ty of de­vel­op­ing a deep re­la­tion­ship with a lead­ing dis­tri­b­u­tion part­ner in Chi­na,” said Ar­ix CEO Joe An­der­son.

Dy­navax $DVAX has bor­rowed $175 mil­lion to launch the new­ly ap­proved Hep­lisav-B. The biotech is get­ting a $100 mil­lion of that now from CRG and has $75 mil­lion avail­able in a sec­ond tranche. The com­pa­ny re­port­ed that it had $192 mil­lion in cash at the end of last year.

→ Cul­li­nan On­col­o­gy, the Cam­bridge, Mass­a­chu­setts-based com­pa­ny that got $150 mil­lion in a Se­ries A back­ing last Oc­to­ber, is team­ing up with Ger­many’s MAB Dis­cov­ery GmbH to de­vel­op an­ti­body ther­a­peu­tics. “We are ex­cit­ed to en­ter in­to this col­lab­o­ra­tion as the MABD de­vel­op­ment en­gine pro­vides us with ac­cess to high­ly dif­fer­en­ti­at­ed mon­o­clon­al an­ti­bod­ies” said Patrick Baeuer­le, Cul­li­nan’s CSO, in a state­ment. “Our first pro­gram is a nov­el ag­o­nis­tic an­ti­body that has the po­ten­tial to be a pil­lar of fu­ture im­muno-on­col­o­gy and stan­dard treat­ments.” The agree­ment does not pro­vide for an up­front pay­ment to MAB Dis­cov­ery. In­stead, MAB Dis­cov­ery re­ceives shares in an un­known amount to Cul­li­nan’s sub­sidiary Cul­li­nan Wit­tels­bach.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.